1. Basic Statement of Need.docx

STATEMENT OF NEED

INSTRUCTIONS: A statement or determination of need is required as part of the supporting documentation for the purchase request when applicable. The Statement of Need (SON) is usually brief and provides the initial documentation of the actual and timely need of the supply or service in support of the mission of the organization. Describing the agency’s needs in these terms allows offerors to propose methods that will best meet the needs of the Government. This document provides an outline for preparing a specific SON. The following information should be included in all SONs:

1. Type of product or service to be acquired;

The purpose of the work is to identify mutations that affect the tenascin-X gene

2. Explanation for how the agency intends to use the product or service in terms of function to be performed; and

We need to perform genetic analysis related to congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. Patients are being seen under the Natural History Study of Patients with Excess Androgens, Protocol # 06-CH-0011. A major goal of this study is to evaluate genetic causes associated with certain clinical conditions. We need to provide results to patient’s, thus we need to use a Clinical Laboratory Improvement Amendments (CLIA) certified lab. This requires sending blood to a CLIA certified commercial laboratory. Prevention Genetics is a CLIA-certified laboratory that offers genetic analysis and genetic sequencing of a gene of interest

3. Performance requirement or essential physical characteristics.

Prevention Genetics is CLIA and ISAP 15189:2012 accredited. The vendor also utilizes data base management which allows for cost savings. Blood and/or DNA will be shipped from NIH to Prevention Genetics according to the NIH regulations and via courier- per company standards.